Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical)

 描述（由申请人提供）：对主诉头晕和失衡的患者进行的医学评估通常包括对其前庭功能的定量评估。临床上批准的测试评估水平半规管目前存在的（热量测试，旋转椅子测试）和一个新的测试，crHIT，具有显着改善的结果，病人的评价相比，现有的测试。然而，为了评估垂直，即，前半规管和后半规管，目前没有既定的测试。计算机化旋转头部冲击测试-垂直（crHIT-垂直）有可能可靠地评估垂直半规管，并对头晕和失衡患者的管理产生重大影响。本阶段SBIR提案的目标是开发附加硬件、分析软件和临床方案，以适应市售临床旋转测试系统，即，神经动力学公司(NKI)I-Portal（r）耳神经测试中心（NOTC）进行这项新的测试，并在有限数量的受试者和前庭患者中验证结果。该项目的长期目标是验证crHIT-垂直的临床有效性，并销售该测试以识别和表征前庭功能不对称的严重程度。本申请的两个具体目标描述了第I阶段SBIR的近期目标。第一个目标是开发crHIT-垂直的临床版本：将所有必要的硬件和软件组件集成到Neuro Kinetics制造的现有商业旋转测试系统中（头枕、六自由度头部传感器的校准程序、刺激输送、数据采集和数据分析）。第二个目标将验证在NKI NOTC系统上对20名前庭功能正常的受试者和20名经验证的前庭垂直通道功能丧失的受试者实施crHIT垂直刺激传递和VOR分析软件。测试将在临床前庭实验室进行，并提供反馈 这将用于评估测试舒适度并改进分析软件的用户界面。临床试验的结果将用于在第二阶段SBIR试验方案之前优化crHIT-垂直。

 DESCRIPTION (provided by applicant): The medical evaluation of patients with complaints of dizziness and disequilibrium often includes a quantitative assessment of their vestibular function. Clinically approved tests for assessing the horizontal semicircular canals currently exis (caloric testing, rotational chair testing) and a new test, crHIT, has the advantage of significanty improving resul0ts of patient evaluation compared to existing tests. However, for assessing the vertical, i.e., the anterior and posterior semicircular canals, there are currently no established tests. The Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical) has the potential to reliably assess the vertical semicircular canals and have a major impact on the management of patients with dizziness and disequilibrium. The goal of this Phase I SBIR proposal is to develop the additional hardware, analysis software, and clinical protocol necessary to adapt a commercially available clinical rotational test system, i.e., the Neuro Kinetics, Inc. (NKI) I-Portal(r) Neuro-Otologic Test Center (NOTC) for performing this new test and validating results on a limited number of subjects and vestibular patients. The long-term aim of this project is to verify the clinical efficiency of crHIT-vertical and sell this test to identify and characterize th severity of an asymmetry of vestibular function. The immediate goals of this Phase I SBIR are described by the two Specific Aims of this application. The first aim is to develop a clinical version of the crHIT-vertical: integrate all of the necessary components of hardware and software into the existing commercial rotational test system manufactured by Neuro Kinetics, (head restraint, calibration procedure for six degrees of freedom head sensor, stimulus delivery, data acquisition, and data analysis). The second aim will verify implementation of the crHIT-vertical stimulus delivery and VOR analysis software on the NKI NOTC system on 20 subjects with normal vestibular function and 20 subjects with a verified vestibular loss of vertical canals function. The tests will be performed in a clinical vestibular laboratory and will provide feedback that will be used to evaluate test comfort and to improve the user interface to the analysis software. The results from the clinical tests will be used to optimize the crHIT- vertical in advance of a Phase II SBIR test protocol.